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A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
ShORe Investigational Site
Phoenix, Arizona, United States
ShORe Investigational Site
Phoenix, Arizona, United States
ShORe Investigational Site
Tucson, Arizona, United States
ShORe Investigational Site
Bakersfield, California, United States
ShORe Investigational Site
Campbell, California, United States
ShORe Investigational Site
Encino, California, United States
ShORe Investigational Site
Fullerton, California, United States
ShORe Investigational Site
Glendale, California, United States
ShORe Investigational Site
Huntington Beach, California, United States
ShORe Investigational Site
Laguna Hills, California, United States
Start Date
March 12, 2021
Primary Completion Date
March 31, 2025
Completion Date
March 31, 2025
Last Updated
July 22, 2025
986
ACTUAL participants
2.0 mg OPT-302
BIOLOGICAL
0.5 mg ranibizumab
BIOLOGICAL
Sham
PROCEDURE
Lead Sponsor
Opthea Limited
NCT05562947
NCT05904028
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06213038